Report generation in a networked health-monitoring system

ABSTRACT

A networked health-monitoring system configured to collect and process patient health-related data. A plurality of remote patient sites, includes at least one display; a data management unit configured to facilitate collection of patient health-related data; a memory and stored program instructions for generating health-monitoring related information on the display. A central server connects to the data management unit at each patient site to receive patient health-related data collected at the remote patient sites. The system produces reports, including standardized reports, from the received data.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a Continuation of U.S. Ser. No. 09/237,194,filed Jan. 26, 1999, which is a Continuation of U.S. Pat. No. 5,899,855,issued May 4, 1999, which is a FWC of U.S. Ser. No. 08/233,397, filedApr. 26, 1994, now abandoned, which is a Continuation of U.S. Pat. No.5,307,263, issued Apr. 26, 1994. This application is also related toapplicant and assignee's co-pending applications listed below: U.S. Pat.No. 5,960,403 (U.S. Ser. No. 09/136,512) which is a Continuation-In-Partof application Ser. No. 08/481,925, filed Jun. 7, 1995, now U.S. Pat.No. 5,899,855, issued on May 4, 1999, which is a FWC of U.S. applicationSer. No. 08/233,397 filed on Apr. 26, 1994, now abandoned, which is aContinuation-In-Part of application Ser. No. 07/977,323, filed Nov. 17,1992, and issued as U.S. Pat. No. 5,307,263. This patent is also aContinuation-In-Part of Application Serial. No. 08/666,242, filed Jun.20, 1996, now abandoned. This application is related to U.S. Pat. No.6,168,563 (U.S. Ser. No. 09/271,217) which is a Continuation-In-Part ofapplication Ser. No. 08/481,925, filed Jun. 7, 1995, now U.S. Pat. No.5,899,855, which is a continuation of application Ser. No. 08/233,397,filed Apr. 26, 1994 (now abandoned), which in turn is aContinuation-In-Part of application Ser. No. 07/977,323, filed Nov. 17,1992 (which has since issued as U.S. Pat. No. 5,307,263); and aContinuation-In-Part of application Ser. No. 08/946,341, filed Oct. 7,1997, now U.S. Pat. No. 5,997,476, which claims priority fromProvisional Application Serial. No. 60/041,746 filed Mar. 28, 1997 andfrom provisional application Ser. No. 60/041,751 filed Mar. 28, 1997;all of which are incorporated herein by reference. This application isrelated to U.S. Pat. No. 5,897,493 (U.S. Ser. No. 08/847,009) which alsoclaims priority from Provisional Application Nos. 60/041,751 and60/041,746 filed Mar. 28, 1997. This application is related to U.S.application Ser. No. 09/658,209 filed on Sep. 8, 2000; U.S. applicationSer. No. 10/233,296 filed on Aug. 30, 2002; U.S. application Ser. No.09/665,242 Mar. 28, 1997; U.S. application Ser. No. 10/319,427 Dec. 12,2002; and U.S. application Ser. No. 09/713,922 Nov. 15, 2000.

BACKGROUND OF INVENTION

[0002] Controlling or curing conditions of ill health generally involvesboth establishing a therapeutic program and monitoring the progress ofthe afflicted person. Based on that progress, decisions can be made asto altering therapy to achieve a cure or maintain the affliction orcondition at a controlled level. Successfully treating certain healthconditions calls for rather frequent monitoring and a relatively highdegree of patient participation. For example, in order to establish andmaintain a regimen for successful diabetes care, a diabetic shouldmonitor his or her blood glucose level and record that information alongwith the date and time at which the monitoring took place. Since diet,exercise, and medication all affect blood glucose levels, a diabeticoften must record data relating to those items of information along withblood glucose level so that the diabetic may more closely monitor his orher condition and, in addition, can provide information of value to thehealthcare provider in determining both progress of the patient anddetecting any need to change the patient's therapy program.

[0003] Advances in the field of electronics over the past several yearshave brought about significant changes in medical diagnostic andmonitoring equipment, including arrangements for self-care monitoring ofvarious chronic conditions. With respect to the control and monitoringof diabetes, relatively inexpensive and relatively easy-to-use bloodglucose monitoring systems have become available that provide reliableinformation that allows a diabetic and his or her healthcareprofessional to establish, monitor and adjust a treatment plan (diet,exercise, and medication). More specifically, microprocessor-based bloodglucose monitoring systems are being marketed which sense the glucoselevel of a blood sample that is applied to a reagent-impregnated regionof a test strip that is inserted in the glucose monitor. When themonitoring sequence is complete, the blood glucose level is displayedby, for example, a liquid crystal display (LCD) unit.

[0004] Typically, currently available self-care blood glucose monitoringunits include a calendar/clock circuit and a memory circuit that allowsa number of blood glucose test results to be stored along with the dateand time at which the monitoring occurred. The stored test results(blood glucose level and associated time and date) can be sequentiallyrecalled for review by the blood glucose monitor user or a healthprofessional by sequentially actuating a push button or other controlprovided on the monitor. In some commercially available devices, theaverage of the blood glucose results that are stored in the monitor (orthe average of the results for a predetermined period of time, e.g.,fourteen days) also is displayed during the recall sequence. Further,some self-care blood glucose monitors allow the user to tag the testresult with an “event code” that can be used to organize the testresults into categories. For example, a user might use a specific eventcode to identify test results obtained at particular times of the day, adifferent event code to identify a blood glucose reading obtained aftera period of exercise, two additional event codes to identify bloodglucose readings taken during hypoglycemia symptoms and hyperglycemiasymptoms, etc. When event codes are provided and used, the event codetypically is displayed with each recalled blood glucose test result.

[0005] Microprocessor-based blood glucose monitoring systems haveadvantages other than the capability of obtaining reliable blood glucosetest results and storing a number of the results for later recall andreview. By using low power microprocessor and memory circuits andpowering the units with small, high capacity batteries (e.g., a singlealkaline battery), extremely compact and light designs have beenachieved that allow taking the blood glucose monitoring system to work,school, or anywhere else the user might go with people encountered bythe user not becoming aware of the monitoring system. In addition, mostmicroprocessor-based self-care blood glucose monitoring systems have amemory capacity that allows the system to be programmed by themanufacturer so that the monitor displays a sequence of instructionsduring any necessary calibration or system tests and during the bloodglucose test sequence itself. In addition, the system monitors varioussystem conditions during a blood glucose test (e.g., whether a teststrip is properly inserted in the monitor and whether a sufficientamount of blood has been applied to the reagent impregnated portion ofthe strip) and if an error is detected generates an appropriate display(e.g., “retest”). A data port may be provided that allows test resultsstored in the memory of the microprocessor-based blood glucosemonitoring system to be transferred to a data port (e.g., RS-232connection) of a personal computer 48 or other such device forsubsequent analysis.

[0006] Microprocessor-based blood glucose monitoring systems are asignificant advance over previously available self-care systems such asthose requiring a diabetic to apply a blood sample to reagent activatedportions of a test strip; wipe the blood sample from the test stripafter a predetermined period of time; and, after a second predeterminedperiod of time, determine blood glucose level by comparing the color ofthe reagent activated regions of the test strip with a color chartsupplied by the test strip manufacturer. Despite what has been achieved,numerous drawbacks and disadvantages still exist. For example,establishing and maintaining diabetic healthcare often requires thediabetic to record additional data pertaining to medication, foodintake, and exercise. However, the event codes of currently availablemicroprocessor blood glucose monitoring systems provide only limitedcapability for tagging and tracking blood glucose test results accordingto food intake and other relevant factors. For example, the event codesof currently available monitoring systems only allow the user toclassify stored blood glucose readings in a manner that indicates bloodglucose tests taken immediately after a heavy, light or normal meal.This method of recording information not only requires subjectivejudgment by the system user, but will not suffice in a situation inwhich successfully controlling the user's diabetes requires therecording and tracking of relatively accurate information relating tofood intake, exercise, or medication (e.g., insulin dosage). Anotherwise significant advantage of currently available blood glucosemonitoring systems is lost when blood glucose test results must berecorded and tracked with quantitative information relating tomedication, food intake, or exercise. Specifically, the system user mustrecord the required information along with a time and date tagged bloodglucose test result by, for example, writing the information in a logbook.

[0007] The use of event codes to establish subcategories of bloodglucose test results has an additional disadvantage or drawback. Inparticular, although alphanumeric display devices are typically used incurrently available microprocessor-based blood glucose monitoringsystems, the display units are limited to a single line of informationhaving on the order of six characters. Moreover, since the systemsinclude no provision for the user to enter alphanumeric information, anyevent codes that are used must be indicated on the display in a genericmanner, e.g., displayed as “EVENT”EVENT etc. This limitation makes thesystem more difficult to use because the diabetic must either memorizehis or her assignment of event codes or maintain a list that defines theevent codes. The limited amount of data that can be displayed at any onetime presents additional drawbacks and disadvantages. First,instructions and diagnostics that are displayed to the user whencalibrating the system and using the system to obtain a blood glucosereading must be displayed a line at a time and in many cases, theinformation must be displayed in a cryptic manner.

[0008] The above-discussed display limitations and other aspects ofcurrently available blood glucose monitoring systems is disadvantageousin yet another way. Little statistical information can be made availableto the user. For example, in diabetic healthcare maintenance, changes orfluctuations that occur in blood glucose levels during a day, a week, orlonger period can provide valuable information to a diabetic and/or hisor her healthcare professional. As previously mentioned, currentlyavailable systems do not allow associating blood glucose test resultswith attendant quantitative information relating to medication, foodintake, or other factors such as exercise that affect a person's bloodglucose level at any particular point in time. Thus, currently availableblood glucose monitoring systems have little or no capability for thegenerating and display of trend information that may be of significantvalue to a diabetic or the diabetic's healthcare professional.

[0009] Some currently available blood glucose monitoring systems providea data port that can be interconnected with and transfer data to apersonal computer 48 (e.g., via an RS-232 connection). With such asystem and a suitable programmed computer, the user can generate anddisplay trend information or other data that may be useful inadministering his or her treatment plan. Moreover, in such systems, dataalso can be transferred from the blood glucose monitoring system to ahealthcare professional's computer either directly or remotely bytelephone if both the blood glucose monitoring system (or computer) towhich the data has been downloaded and the healthcare professional'scomputer are equipped with modems. Although such a data transferprovision allows a healthcare professional to analyze blood glucose datacollected by a diabetic, this aspect of currently available bloodglucose monitoring systems has not found widespread application. First,the downloading and subsequent analysis feature can only be used bysystem users that have ready access to a computer that is programmedwith appropriate software and, in addition, have both the knowledgerequired to use the software (and the inclination to do so). This sameproblem exists with respect to data transfer to (and subsequent analysisby) a healthcare professional. Moreover, various manufacturers ofsystems that currently provide a data transfer feature do not use thesame data format. Therefore, if a healthcare professional wishes toanalyze data supplied by a number of different blood glucose monitoringsystems, he or she must possess software for each of the systems andmust learn to conduct the desired analyses with each software system.

[0010] The above-discussed disadvantages and drawbacks ofmicroprocessor-based self-care health monitoring systems take on evengreater significance with respect to children afflicted with diabetes,asthma and other chronic illnesses. In particular, a child's need formedication and other therapy changes as the child grows. Currentmicroprocessor-based self-care health monitoring systems generally donot provide information that is timely and complete enough for ahealthcare professional to recognize and avert problems beforerelatively severe symptoms develop. Too often, a need for a change inmedication and/or other changes in therapeutic regimen is not detecteduntil the child's condition worsens to the point that emergency roomcare is required.

[0011] Further, currently available microprocessor-based healthmonitoring systems have not been designed with children in mind. Aspreviously mentioned, such devices are not configured for sufficientease of use in situations in which it is desirable or necessary torecord and track quantitative information that affects the physicalcondition of the system user (e.g., medication dosage administered by adiabetic and food intake). Children above the age at which they aregenerally capable of obtaining blood samples and administering insulinor other medication generally can learn to use at least the basic bloodglucose monitoring features of currently available microprocessor-basedblood glucose monitoring systems. However, the currently availablemonitoring systems provide nothing in the way of motivation for a childto use the device and, in addition, include little or nothing thateducates the child about his or her condition or treatment progress.

[0012] The lack of provision for the entering of alphanumeric data alsocan be a disadvantage. For example, currently available blood glucosemonitoring systems do not allow the user or the healthcare professionalto enter information into the system such as medication dosage and otherinstructions or data that is relevant to the user's self-care healthprogram.

[0013] The above-discussed disadvantages and drawbacks of currentlyavailable microprocessor-based blood glucose monitoring systems alsohave been impediments to adopting the basic technology of the system forother healthcare situations in which establishing and maintaining aneffective regimen for cure or control is dependent upon (or at leastfacilitated by) periodically monitoring a condition and recording thatcondition along with time and date tags and other information necessaryor helpful in establishing and maintaining a healthcare program.

SUMMARY OF INVENTION

[0014] This invention provides a new and useful system for healthcaremaintenance in which the invention either serves as a peripheral deviceto (or incorporates) a small handheld microprocessor-based unit of thetype that includes a display screen, buttons or keys that allow a userto control the operation of the device and a program cartridge or otherarrangement that can be inserted in the device to adapt the device to aparticular application or function. The invention in effect converts thehandheld microprocessor device into a healthcare monitoring system thathas significant advantages over systems such as the currently availableblood glucose monitoring systems. To perform this conversion, theinvention includes a microprocessor-based healthcare data managementunit, a program cartridge and a monitoring unit. When inserted in thehandheld microprocessor unit 12, the program cartridge provides thesoftware necessary (program instructions) to program the handheldmicroprocessor unit 12 for operation with the microprocessor-based datamanagement unit. Signal communication between the data management unitand the handheld microprocessor unit 12 is established by an interfacecable. A second interface cable can be used to establish signalcommunication between the data management unit and the monitoring unitor, alternatively, the monitoring unit can be constructed as a plug-inunit having an electrical connector that mates with a connector mountedwithin a region that is configured for receiving the monitoring unit.

[0015] In operation, the control buttons or keys of the handheldmicroprocessor-based unit are used to select the operating mode for boththe data management unit and the handheld microprocessor-based unit. Inresponse to signals generated by the control buttons or keys, the datamanagement unit generates signals that are coupled to the handheldmicroprocessor unit 12 and, under control of the program instructionscontained in the program cartridge, establish an appropriate screendisplay on the handheld microprocessor-based unit display. In selectingsystem operating mode and other operations, the control buttons are usedto position a cursor or other indicator in a manner that allows thesystem user to easily select a desired operating mode or function andprovide any other required operator input. In the disclosed detailedembodiment of the invention several modes of operation are madeavailable.

[0016] In the currently preferred embodiments of the invention, thehandheld microprocessor unit 12 is a compact video game system such asthe system manufactured by Nintendo of America Inc. under the trademark“GAME BOY.” Use of a compact video game system has several generaladvantages, including the widespread availability and low cost of suchsystems. Further, such systems include switch arrangements that areeasily adapted for use in the invention and the display units of suchsystems are of a size and resolution that can advantageously be employedin the practice of the invention. In addition, such systems alloweducational or motivational material to be displayed to the system user,with the material being included in the program cartridge that providesthe monitor system software or, alternatively, in a separate programcartridge.

[0017] The use of a compact video game system for the handheldmicroprocessor-based unit of the invention is especially advantageouswith respect to children. Specifically, the compact video game systemsof the type that can be employed in the practice of the invention arewell known and well accepted by children. Such devices are easilyoperated by a child and most children are well accustomed to using thedevices in the context of playing video games. Motivational andeducational material relating to the use of the invention can bepresented in game-like or animated format to further enhance acceptanceand use of the invention by children that require self-care healthmonitoring.

[0018] A microprocessor-based health monitoring system that isconfigured in accordance with the invention provides additionaladvantages for both the user and a healthcare professional. Inaccordance with one aspect of the invention, standardized reports areprovided to a physician or other healthcare provider by means offacsimile transmission. To accomplish this, the data management unit ofthe currently preferred embodiments of the invention include a modemwhich allows test results and other data stored in system memory to betransmitted to a remote clearinghouse via a telephone connection. Dataprocessing arrangements included in the clearinghouse perform anyrequired additional data processing; format the standardized reports;and, transmit the reports to the facsimile machine of the appropriatehealthcare professional.

[0019] The clearinghouse also can fill an additional communication need,allowing information such as changes in medication dosage or otherinformation such as modification in the user's monitoring schedule to beelectronically sent to a system user. In arrangements that incorporatethis particular aspect of the invention, information can be sent to theuser via a telephone connection and the data management unit modem whena specific inquiry is initiated by the user, or when the userestablishes a telephone connection with the clearinghouse for otherpurposes such as providing data for standardized reports.

[0020] The clearinghouse-facsimile aspect of the invention is importantbecause it allows a healthcare professional to receive timelyinformation about patient condition and progress without requiring avisit by the patient (system user) and without requiring analysis orprocessing of test data by the healthcare professional. In this regard,the healthcare professional need not possess or even know how to use acomputer and/or the software conventionally employed for analysis ofblood glucose and other health monitoring data and information.

[0021] The invention also includes provision for data analysis andmemory storage of information provided by the user and/or the healthcareprofessional. In particular, the data management units of the currentlypreferred embodiments of the invention include a data port such as anRS-232 connection that allows the system user or healthcare professionalto establish signal communication between the data management unit and apersonal computer or other data processing arrangement. Blood glucosetest data or other information can then be downloaded for analysis andrecord keeping purposes. Alternatively, information such as changes inthe user's treatment and monitoring regimen can be entered into systemmemory. Moreover, if desired, remote communication between the datamanagement unit and the healthcare professional's computer can beestablished using the clearinghouse as an element of the communicationslink. That is, in the currently preferred arrangements of the inventiona healthcare professional has the option of using a personal computerthat communicates with the clearinghouse via a modem and telephone linefor purposes of transmitting instructions and information to a selecteduser of the system and/or obtaining user test data and information forsubsequent analysis.

[0022] The invention can be embodied in forms other than those describedabove. For example, although small handheld microprocessorunits such asa handheld video game system or handheld microprocessorunits of the typeoften referred to as “palmcomputers provide many advantages, there aresituations in which other compact microprocessorunits can advantageouslybe used. Among the various types of units that can be employed are usingcompact video game systems of the type that employ a program cartridge,but uses a television set or video monitor instead of a display unitthat is integrated into the previously described handheldmicroprocessorunits.

[0023] Those skilled in the art also will recognize that theabove-described microprocessor-implemented functions and operations canbe apportioned between one or more microprocessors in a manner thatdiffers from the above-described arrangement. For example, in somesituations, the programmable microprocessorunit and the programcartridge used in practicing the invention may provide memory and signalprocessing capability that is sufficient for practicing the invention.In such situations, the microprocessor of the microprocessor-based datamanagement unit of the aboveembodiments in effect is moved into thevideo game system, palmcomputer or programmable microprocessor device.In such an arrangement, the data management unit can be realized as arelatively simple interface unit that includes little or no signalprocessing capability. Depending upon the situation at hand, theinterface unit may or may not include a telephone modem and/or anRSconnection (or other data port) for interconnecting the healthcaresystem with a computer or other equipment. In other situations, thefunctions and operations associated with processing of the monitoredhealth care data may be performed by a microprocessor that is added toor already present in the monitoring device that is used to monitorblood glucose or other condition.

[0024] Because the invention can be embodied to establish systems havingdifferent levels of complexity, the invention satisfies a wide range ofself-care health monitoring applications. The arrangements that includea modem (or other signal transmission facility) and sufficient signalprocessing capability can be employed in situations in which reports areelectronically transmitted to a healthcare professional either in hardcopy (facsimile) form or in a signal format that can be received by andstored in the healthcare professional's computer. On the other hand,less complex (and, hence, less costly) embodiments of the invention areavailable for use in which transfer of system information need not bemade by means of telephonic data transfer or other remote transmissionmethods. In these less complex embodiments, transfer of data to ahealthcare professional can still be accomplished. Specifically, if theprogram cartridge includes a battery and suitable program instructions,monitored healthcare data can be stored in the program cartridge duringuse of the system as a healthcare monitor. The data cartridge can thenbe provided to the healthcare professional and inserted in aprogrammable microprocessorunit that is the same as or similar to thatwhich was used in the healthcare monitoring system. The healthcareprofessional can then review the data, and record it for later use,and/or can use the data in performing various analyses. If desired, themicroprocessorunit used by the healthcare professional can be programmedand arranged to allow information to be stored in the cartridge forreturn to and retrieval by the user of the healthcare monitoring system.The stored information can include messages (e.g., instructions forchanges in medication dosage) and/or program instructions forreconfiguring the program included in the cartridge so as to effectchanges in the treatment regimen, the analyses or reports to begenerated by the healthcare monitoring system, or less important aspectssuch as graphical presentation presented during the operation of thehealth care system.

BRIEF DESCRIPTION OF DRAWINGS

[0025] The foregoing aspects and many of the attendant advantages ofthis invention will become more readily appreciated as the same becomesbetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

[0026]FIG. 1 is a block diagram that illustrates a healthcare monitoringsystem arranged in accordance with the invention;

[0027]FIG. 2 diagrammatically illustrates monitoring systems constructedin accordance with the invention connected in signal communication witha remotely located computing facility which includes provision formaking the data supplied by the monitoring system of the inventionavailable to a designated healthcare professional and/or for providingdata and instructions to the system user;

[0028]FIG. 3 is a block diagram diagrammatically depicting thestructural arrangement of the system data management unit and itsinterconnection with other components of the system shown in FIG. 1;

[0029] FIGS. 4-10 depict typical system screen displays of data andinformation that can be provided by the arrangements shown in FIGS. 1-3;and

[0030]FIG. 11 diagrammatically illustrates an alternative healthcaremonitoring system that is arranged in accordance with the invention.

DETAILED DESCRIPTION

[0031]FIG. 1 depicts a self-care health monitoring system arranged inaccordance with the invention. In the arrangement shown in FIG. 1 a datamanagement unit 10 is electrically interconnected with a handheldmicroprocessor-based unit 12 via a cable 14. In the depictedarrangement, data management unit 10 also is electrically interconnectedwith a blood glucose monitor 16 of the type capable of sensing bloodglucose level and producing an electrical signal representative thereof.Although FIG. 1 illustrates blood glucose monitor 16 as being connectedto data management unit 10 by a cable 18 it may be preferable toconstruct blood glucoase monitor 16 as a plug-in unit that is placed ina recess or other suitable opening or slot in data management unit 10.Regardless of the manner in which blood glucose monitor 16 isinterconnected with data management unit 10 both that interconnectionand cable 14 are configured for serial data communication between theinterconnected devices.

[0032] Also shown in FIG. 1 are two additional monitoring devices 20 and22 which are electrically connected for serial data communication withdata management unit 10 via cables 24 and 26 respectively. Monitoringunits 20 and 22 of FIG. 1 represent devices other than blood glucosemonitor 16 that can be used to configure the invention for self-carehealth monitoring applications other than (or in addition to) diabetescare. For example, as is indicated in FIG. 1 the monitoring device 20can be a peak-flow meter that provides a digital signal representativeof the airflow that results when a person suffering from asthma oranother chronic respiratory affliction expels a breath of air throughthe meter. As is indicated by monitor 22 of FIG. 1 various other devicescan be provided for monitoring conditions such as blood pressure, pulse,and body temperature to thereby realize systems for self-care monitoringand control of conditions such as hypertension, certain heart conditionsand various other afflictions and physical conditions. Uponunderstanding the hereinafter discussed aspects and features of theinvention it will be recognized that the invention is easily implementedfor these and other types of healthcare monitoring. In particular,monitors used in the practice of the invention can be arranged in avariety of ways as long as the data to be recorded or otherwise employedby handheld microprocessor unit 12 and/or data management unit 10 isprovided in serial format in synchronization with clock signals providedby data management unit 10. As is the case with blood glucose monitor 16the additional monitors can be configured as plug-in units that aredirectly received by data management unit 10 or can be connected to datamanagement unit 10 with cables (as shown in FIG. 1). As is shown in FIG.1, handheld microprocessor unit 12 includes a display screen 28 and aplurality of switches or keys (30,32, 34, 36, and 38 in FIG. 1) whichare mounted on a housing 40 Located in the interior of housing 40 butnot shown in FIG. 1 are a microprocessor, memory circuits, and circuitrythat interfaces switches 30, 32, 34, 36 and 38 with the microprocessor.Stored in the memory of program handheld microprocessor unit 12 is a setof program instructions that establishes a data protocol that allowshandheld microprocessor unit 12 to perform digital data signalprocessing and generate desired data or graphics for display on displayunit 28 when a program cartridge 42 is inserted in a slot or otherreceptacle in housing 40 That is, program cartridge 42 of FIG. 1includes read-only memory units (or other memory means such asbattery-powered random access memory) which store program instructionsand data that adapt handheld microprocessor for operation in a bloodglucose monitoring system. More specifically, when the instructions anddata of program cartridge 42 are combined with program instructions anddata included in the internal memory circuits of handheld microprocessorunit 12 handheld microprocessor unit 12 is programmed for processing anddisplaying blood glucose information in the manner described below andadditional monitors to provide health monitoring for asthma and variousother previously mentioned chronic conditions. In each case, theplurality of switches or keys (30,32, 34, 36, and 38 in FIG. 1) areselectively operated to provide signals that result in pictorial and/oralphanumeric information being displayed by display unit 28 Variousdevices are known that meet the above-set forth description of handheldmicroprocessor unit 12 For example, compact devices are available inwhich the plurality of keys allows alphanumeric entry and internalmemory is provided for storing information such as names, addresses,phone numbers, and an appointment calendar. Small program cartridge orcards can be inserted in these devices to program the device for variouspurposes such as the playing of games, spreadsheet application, andforeign language translation sufficient for use in travel. Morerecently, less compact products that have more extensive computationalcapability and are generally called “palm top computers” have beenintroduced into the marketplace. These devices also can includeprovision for programming the device by means of an insertable programcard or cartridge.

[0033] The currently preferred embodiments of the invention areconfigured and arranged to operate in conjunction with yet another typeof handheld microprocessor unit 12. Specifically, in the currentlypreferred embodiments of the invention, program cartridge 42 iselectrically and physically compatible with commercially availablecompact video game systems, such as the system manufactured by Nintendoof America Inc. under the trademark “GAME BOY.” Configuring datamanagement unit 10 and program cartridge 42 for operation with ahandheld video game system has several advantages. For example, thedisplay unit 28 of such a device provides display resolution that allowsthe invention to display both multi-line alphanumeric information andgraphical data. In this regard, the 160×144 pixel dot matrix-type liquidcrystal display screen 28 currently used in the above-referenced compactvideo game systems provides sufficient resolution for at least six linesof alphanumeric text, as well as allowing graphical representation ofstatistical data such as graphical representation of blood glucose testresults for a day, a week, or longer.

[0034] Another advantage of realizing handheld microprocessor unit 12 inthe form of a compact video game system is the relatively simple, yetversatile arrangement of switches that is provided by such a device. Forexample, as is indicated in FIG. 1 a compact video game system includesa control pad 30 that allows an object displayed on display unit 28 tobe moved in a selected direction (i.e., up-down or left-right). As alsois indicated in FIG. 1 compact video game systems typically provide twopair of distinctly-shaped push button switches. In the arrangement shownin FIG. 1 a pair of spaced-apart circular push button switches (36 and38) and a pair of elongate switches (32 and 34) are provided. Thefunctions performed by the two pairs of switches is dependent upon theprogram instructions contained in each program cartridge 42. Yet anotheradvantage of utilizing a compact video game system for handheldmicroprocessor-based unit of FIG. 1 is the widespread popularity and lowcost of such units. In this regard, manufacture and sale of a datamanagement unit 10 blood glucoase monitor 16 and program cartridge 42that operate in conjunction with a compact microprocessor-based videoallows the self-care health monitoring system of FIG. 1 to bemanufactured and sold at a lower cost than could be realized in anarrangement in which handheld unit is designed and manufactured solelyfor use in the system of FIG. 1. An even further advantage of using acompact video game system for handheld microprocessor is that such videogame systems include means for easily establishing the electricalinterconnection provided by cable in FIG. 1. In particular, such compactvideo game systems include a connector mounted to the game unit housing(40 in FIG. 1) and a cable that can be connected between the connectorsof two video game units to allow interactive operation of the twointerconnected units (i.e., to allow contemporaneous game play by twoplayers or competition between players as they individually playidentical but separate games). In the preferred embodiments of theinvention, the “two-player” cable supplied with the compact video gameunit being used as handheld microprocessor unit 12 is used as cable toestablish serial data communication between the handheld microprocessorunit 12 (compact video game system) and data management unit 10 In thesepreferred embodiments, the program instructions stored on the memory ofdata management unit 10 and program cartridge 42 respectively programdata management unit 10 and the compact video game system (i.e.,handheld microprocessor unit 12) for interactive operation in whichswitches 30, 32, 34, 36 and 38 are used to control the operation of datamanagement unit 10 (e.g., to select a particular operational mode suchas performance of a blood glucose test or the display of statisticaltest data and, in addition, to control operation such as selection of anoption during operation of the system in a particular operational mode).In each operational mode, data management unit 10 processes data inaccordance with program instructions stored in the memory circuits ofdata management unit 10 Depending upon the operational mode selected bythe user, data is supplied to data management unit 10 by blood glucoasemonitor 16 by additional monitors (20 and 22 in FIG. 1) or anyinterconnected computers or data processing facility (such as thehereinafter described user's computer 48 and clearinghouse 54 of FIG. 1)During such operation, mode switches and are selectively activated sothat signals are selectively coupled to the video game system (handheldmicroprocessor unit 12 and processed in accordance with programinstructions stored in program cartridge 42 The signal processingperformed by handheld microprocessor unit 12 results in the display ofalphanumeric, symbolic, or graphic information on the video game displayscreen 28 (i.e., display unit 28 in FIG. 1 which allow the user tocontrol system operation and obtain desired test results and otherinformation.

[0035] Although the above-discussed advantages apply to use of theinvention by all age groups, employing a compact video game system inthe practice of the invention is of special significance in monitoring achild's blood glucose or other health parameters. Children and youngadults are familiar with compact video game systems. Thus, children willaccept a health monitoring system incorporating a compact video gamesystem more readily than a traditional system, even an embodiment of theinvention that uses a different type of handheld microprocessor unit 12.Moreover, an embodiment of the invention that functions in conjunctionwith a compact video game system can be arranged to motivate children tomonitor themselves more closely than they might otherwise byincorporating game-like features and/or animation in system instructionand test result displays. Similarly, the program instructions can beincluded in program cartridge 41, 42 and 43 (or additional cartridges)that allow children to select game-like displays that help educate thechild about his or her condition and the need for monitoring.

[0036] With continued reference to FIG. 1 data management unit 10 of thecurrently preferred embodiments of the invention includes a data port 44that allows communication between data management unit 10 and a personalcomputer 48 (or other programmable data processor). In the currentlypreferred embodiments of the invention, data por 44 tis an RS-232connection that allows serial data communication between data managementunit 10 and personal computer 48. In the practice of the invention,personal computer 48 can be used to supplement data management unit 10by, for example, performing more complex analyses of blood glucose andother data that has been supplied to and stored in the memory circuitsof data management unit 10. With respect to embodiments of the inventionconfigured for use by a child, personal computer 48 can be used by aparent or guardian to review and analyze the child's progress and toproduce printed records for subsequent review by a healthcareprofessional. Alternatively, personal computer 48 can be used to supplydata to data management unit 10 that is not conveniently supplied byusing handheld microprocessor switches and as an operator interface tothe system shown in FIG. 1. For example, some embodiments of theinvention may employ a substantial amount of alphanumeric informationthat must be entered by the system user. Although it is possible toenter such data by using switches 30, 32, 34, 36 and 38 in conjunctionwith menus and selection screens displayed on display screen 28 of FIG.1 it may be more advantageous to use a device such as personal computer48 for entry of such data. However, if personal computer 48 is used inthis manner, some trade-off of system features may be required becausedata management unit 10 must be temporarily interconnected with personalcomputer 48 during these operations. That is, some loss of systemmobility might result because a suitably programmed personal computer 48would be needed at each location at which data entry or analysis is tooccur.

[0037] As is indicated in FIG. 1 data management unit 10 of thecurrently preferred embodiments of the invention also includes a modemthat allows data communication between data management unit 10 and aremote computing facility identified in FIG. 1 as clearinghouse 54 via aconventional telephone line 64 (indicated by reference numeral 50 inFIG. 1 and a modem 52 that interconnects clearinghouse 54 and telephoneline 50. As shall be described in more detail, clearinghouse computingfacility 54 facilitates communication between a user of the system shownin FIG. 1 and his or her healthcare professional and can provideadditional services such as updating system software. As is indicated byfacsimile machine 55 of FIG. 1, a primary function of clearinghouse 54is providing the healthcare professional with standardized reports 56,which indicate both the current condition and condition trends of thesystem user. Although a single facsimile machine 55 is shown in FIG. 1it will be recognized that numerous healthcare professionals (and hencefacsimile machine 55 can be connected in signal communication with aclearinghouse 54 Regardless of whether a compact video game system,another type of commercially available handheld microprocessor-basedunit, or a specially designed unit is used, the preferred embodiments ofFIG. 1 provide a self-care blood glucose monitoring system in whichprogram cartridge 42 (a) handheld microprocessor unit 12 for displayinginstructions for performing the blood glucose test sequence andassociated calibration and test procedures; (b) handheld microprocessorunit 12 for displaying (graphically or alphanumerically) statisticaldata such as blood glucose test results taken during a specific periodof time (e.g., a day, week, etc.); (c) handheld microprocessor unit 12for supplying control signals and signals representative of food intakeor other useful information to data management unit 10 (d) handheldmicroprocessor unit 12 for simultaneous graphical display of bloodglucose levels with information such as food intake; and, (e) handheldmicroprocessor unit 12 for displaying information or instructions from ahealthcare professional that are coupled to data management unit 10 froma clearinghouse 54 The manner in which the arrangement of FIG. 1implements the above-mentioned functions and others can be betterunderstood with reference to FIGS. 2 and 3. Referring first to FIG. 1clearinghouse 54 receives data from a plurality of self-caremicroprocessor-based healthcare systems of the type shown in FIG. 1 withthe individual self-care health monitoring systems being indicated inFIG. 2 by reference numeral Preferably, the data supplied toclearinghouse 54 by each individual self-care health monitoring systemconsists of “raw data,” i.e., test results and related data that wasstored in memory circuits of data management unit 10 without furtherprocessing by data management unit 10. For example, with respect to thearrangement shown in FIG. 1 blood glucose test results and associateddata such as food intake information, medication dosage and other suchconditions are transmitted to clearinghouse 54 and stored with adigitally encoded signal that identifies both the source of theinformation (i.e., the system user or patient) and those having accessto the stored information (i.e., the system user's doctor or otherhealthcare professional).

[0038] As shall be recognized upon understanding the manner in which itoperates, clearinghouse 54 can be considered to be a central server forthe various system users (58 in FIG. 2) and each healthcare professional60. In that regard, clearinghouse 54 includes conventionally arrangedand interconnected digital processing equipment (represented in FIG. 2by digital signal processor 57) which receives digitally encodedinformation from a user 58 or healthcare professional 60; processes theinformation as required; stores the information (processed orunprocessed) in memory if necessary; and, transmits the information toan intended recipient (i.e., user 58 or healthcare professional 60. InFIG. 2 rectangular outline 60 represents one of numerous remotelylocated healthcare professionals who can utilize clearinghouse 54 andthe arrangement described relative to FIG. 1 in monitoring andcontrolling patient healthcare programs. Shown within outline 60 is acomputer 62 (e.g., personal computer), which is coupled to clearinghouse54 by means of a modem (not shown in FIG. 2 and a telephone line 64.Also shown in FIG. 2 is the previously mentioned 55 which is coupled toclearinghouse 54 by means of a second telephone line 68 Using theinterface unit of computer 62 (e.g., a keyboard or pointing device suchas a mouse), the healthcare professional can establish datacommunication between computer 62 and clearinghouse 54 via telephoneline Once data communication is established between computer andclearinghouse 54 patient information can be obtained from clearinghouse54 in a manner similar to the manner in which subscribers to variousdatabase services access and obtain information. In particular, thehealthcare professional can transmit an authorization code toclearinghouse 54 that identifies the healthcare professional as anauthorized user of the clearinghouse 54 and, in addition, can transmit asignal representing the patient for which healthcare information isbeing sought. As is the case with conventional database services andother arrangements, the identifying data is keyed into computer by meansof a conventional keyboard (not shown in FIGURE in response to promptsthat are generated at clearinghouse 54 for display by the display unit28 of computer (not shown in FIG. 2 Depending upon the hardware andsoftware arrangement of clearinghouse 54 and selections made by thehealthcare professional via computer patient information can be providedto the healthcare professional in different ways. For example, computer62 can be operated to access data in the form that it is stored in thememory circuits of clearinghouse 54 (i.e., raw data that has not beenprocessed or altered by the computational or data processingarrangements of clearinghouse 54 Such data can be processed, analyzed,printed and/or displayed by computer using commercially available orcustom software. On the other hand, various types of analyses may beperformed by clearinghouse 54 with the results of the analyses beingtransmitted to the remotely located healthcare professional For example,clearinghouse 54 can process and analyze data in a manner identical tothe processing and analysis provided by the self-care monitoring systemof FIG. 1 With respect to such processing and any other analysis andprocessing provided by clearinghouse 54 results expressed inalphanumeric format can be sent to computer via telephone line 50 andthe modem associated with computer with conventional techniques beingused for displaying and/or printing the alphanumeric material forsubsequent reference.

[0039] The arrangement of FIG. 2 also allows the healthcare professionalto send messages and/or instructions to each patient via computertelephone line and clearinghouse 54 In particular, clearinghouse 54 canbe programmed to generate a menu that is displayed by computer andallows the healthcare professional to select a mode of operation inwhich information is to be sent to clearinghouse 54 for subsequenttransmission to a user of the system described relative to FIG. 1 Thissame menu (or related submenus) can be used by the healthcareprofessional to select one or more modes of operation of theabove-described type in which either unmodified patient data or theresults of data that has been analyzed by clearinghouse 54 is providedto the healthcare provider via computer and/or facsimile machine 55 Inthe currently contemplated arrangements, operation of the arrangement ofFIG. 2 to provide the user of the invention with messages orinstructions such as changes in medication or other aspects of thehealthcare program is similar to the operation that allows thehealthcare professional to access data sent by a patient, i.e.,transmitted to clearinghouse 54 by a data management unit 10 of FIG. 1The process differs in that the healthcare professional enters thedesired message or instruction via the keyboard or other interface unitof computer Once the data is entered and transmitted to clearinghouse 54it is stored for subsequent transmission to the user for whom theinformation or instruction is intended.

[0040] With respect to transmitting stored messages or instructions to auser of the invention, at least two techniques are available. The firsttechnique is based upon the manner in which operational modes areselected in the practice of the invention. Specifically, in thecurrently preferred embodiments of the invention, program instructionsthat are stored in data management unit 10 and program cartridge 42cause the system of FIG. 1 to generate menu screens which are displayedby display unit 28 of handheld microprocessor unit 12 The menu screensallow the system user to select the basic mode in which the system ofFIG. 1 is to operate and, in addition, allow the user to selectoperational subcategories within the selected mode of operation. Varioustechniques are known to those skilled in the art for displaying andselecting menu items. For example, in the practice of this invention,one or more main menus can be generated and displayed which allow thesystem user to select operational modes that may include: (a) a monitormode (e.g., monitoring of blood glucose level); (b) a display mode(e.g., displaying previously obtained blood glucose test results orother relevant information); (c) an input mode (e.g., a mode forentering data such as providing information that relates to thehealthcare regimen, medication dosage, food intake, etc.); and, (d) acommunications mode (for establishing a communication link between datamanagement unit 10 and personal computer 48 of FIG. 1 or between datamanagement unit 10 and a remote computing facility such as clearinghouse54 of FIG. 2). In embodiments of the invention that employ a compactvideo game system for handheld microprocessor unit 12 the selection ofmenu screens and the selection of menu screen items preferably isaccomplished in substantially the same manner as menu screens and menuitems are selected during the playing of a video game. For example, theprogram instructions stored in data management unit 10 and programcartridge 42 of the arrangement of FIG. 1 can be established so that apredetermined one of the compact video game switches (e.g., switch 32 inFIG. 1 allows the system user to select a desired main menu in the eventthat multiple main menus are employed. When the desired main menu isdisplayed, operation by the user of control pad 30 allows a cursor orother indicator that is displayed on the menu to be positioned adjacentto or over the menu item to be selected. Activation of a switch (e.g.,switch of the depicted handheld microprocessor unit 12 causes thehandheld microprocessor unit 12 and/or data management unit 10 toinitiate the selected operational mode or, if selection of operationalsubmodes is required, causes handheld microprocessor unit 12 to displaya submenu.

[0041] In view of the above-described manner in which menus and submenusare selected and displayed, it can be recognized that the arrangement ofFIG. 1 can be configured and arranged to display a menu or submenu itemthat allows the user to obtain and display messages or instructions thathave been provided by a healthcare professional and stored inclearinghouse 54 For example, a submenu that is generated upon selectionof the previously mentioned communications mode can include submenuitems that allow the user to select various communication modes,including a mode in which serial data communication is establishedbetween data management unit 10 and clearinghouse 54 and data managementunit 10 transmits a message status request to clearinghouse 54 When thistechnique is used, the data processing system of clearinghouse 54 isprogrammed to search the clearinghouse 54 memory to determine whether amessage exists for the user making the request. Any messages stored inmemory for that user are then transmitted to the user and processed fordisplay on display unit 28 of handheld microprocessor unit 12 If nomessages exist, clearinghouse 54 transmits a signal that causes displayunit 28 to indicate “no messages.” In this arrangement, clearinghouse 54preferably is programmed to store a signal indicating that a storedmessage has been transmitted to the intended recipient (user). Storingsuch a signal allows the healthcare professional to determine thatmessages sent to clearinghouse 54 for forwarding to a patient have beentransmitted to that patient. In addition, the program instructionsstored in data management unit 10 of FIG. 1 preferably allow the systemuser to designate whether received messages and instructions are to bestored in the memory of data management unit 10 for subsequent retrievalor review. In addition, in some instances it may be desirable to programclearinghouse 54 and data management unit 10 so that the healthcareprofessional can designate (i.e., flag) information such as changes inmedication that will be prominently displayed to the user (e.g.,accompanied by a blinking indicator) and stored in the memory of datamanagement unit 10 regardless of whether the system user designates theinformation for storage.

[0042] A second technique that can be used for forwarding messages orinstructions to a user does not require the system user to select a menuitem requesting transmission by clearinghouse 54 of messages that havebeen stored for forwarding to that user. In particular, clearinghouse 54can be programmed to operate in a manner that either automaticallytransmits stored messages for that user when the user operates thesystem of FIG. 1 to send information to the clearinghouse 54 orprogrammed to operate in a manner that informs the user that messagesare available and allows the user to access the messages when he or shechooses to do so.

[0043] Practicing the invention in an environment in which thehealthcare professional uses a personal computer in some or all of theabove-discussed ways can be very advantageous. On the other hand, theinvention also provides healthcare professionals timely informationabout system users without the need for a computer (62 in FIG. 2) or anyequipment other than a conventional facsimile machine (55 in FIGS. 1 and2). Specifically, information provided to clearinghouse 54 by a systemuser can be sent to a healthcare professional 60 via telephone line 68and facsimile machine 55 with the information being formatted as astandardized graphic or textual report (56 in FIG. 1 Formatting astandardized report 56 (i.e., analyzing and processing data supplied byblood glucoase monitor 16 or other system monitor or sensor) can beeffected either by data management unit 10 or within the clearinghouse54 facility. Moreover, various standardized reports can be provided(e.g., the textual and graphic displays discussed below relating toFIGS. 6-10) Preferably, the signal processing arrangement included inclearinghouse 54 allows each healthcare professional 60 to select whichof several standardized reports will be routinely transmitted to thehealthcare professionals' facsimile 55, and, to do so on apatient-by-patient (user-by-user) basis.

[0044]FIG. 3 illustrates the manner in which data management unit 10 isarranged and interconnected with other system components for effectingthe above-described operational aspects of the invention and additionalaspects that are described relative to FIGS. 4-10. As is symbolicallyindicated in FIG. 3 handheld microprocessor unit 12 and blood glucoasemonitor 16 are connected to a dual universal asynchronous receivertransmitter 70 (e.g., by cables 14 and 18 of FIG. 1 respectively). Asalso is indicated in FIG. 3 when a system user connects a personalcomputer 48 (or other programmable digital signal processor) to dataport 44, signal communication is established between personal computer48 and a second dual universal asynchronous receiver transmitter 72 ofdata management unit 10. Additionally, dual universal asynchronousreceiver transmitter 72 is coupled to modem 46 so that datacommunication can be established between data management unit 10 and aremote clearinghouse 54 of FIGS. 1 and 2. Currently preferredembodiments of data management unit 10 include a plurality of signalsensors 74, with an individual signal sensor being associated with eachdevice that is (or may be) interconnected with data management unit 10.As previously discussed and as is indicated in FIG. 3, these devicesinclude handheld microprocessor unit 12, blood glucoase monitor 16,personal computer 48, remote computing facility 54 and, in addition,peak-flow meter 20 or other additional monitoring devices. Each signalsensor 74 that is included in data management unit 10 is electricallyconnected for receiving a signal that will be present when the devicewith which that particular signal sensor is associated is connected todata management unit 10 and, in addition, is energized (e.g., turnedon). For example, in previously mentioned embodiments of the inventionin which data port 44 is an RS-232 connection, the signal sensor 74 thatis associated with personal computer 48 can be connected to an RS-232terminal that is supplied power when a personal computer is connected todata port 44 and the personal computer is turned on. In a similarmanner, the signal sensor 74 that is associated with clearinghouse 54can be connected to modem 46 so that the signal sensor 74 receives anelectrical signal when modem 46 is interconnected to a remote computingfacility (e.g., clearinghouse 54 of FIG. 2) via a telephone line 50. Inthe arrangement of FIG. 3, each signal sensor 74 is a low power switchcircuit (e.g., a metal-oxide semiconductor field-effect transistorcircuit), which automatically energizes data management unit 10 wheneverany one (or more) of the devices associated with signal sensors 74 isconnected to data management unit 10 and is energized. Thus, as isindicated in FIG. 3 by signal path 76 each signal sensor 74 isinterconnected with power supply 78 which supplies operating current tothe circuitry of data management unit 10 and typically consists of oneor more small batteries (e.g., three AAA alkaline cells).

[0045] The microprocessor and other conventional circuitry that enablesdata management unit 10 to process system signals in accordance withstored program instructions is indicated in FIG. 3 by central processingunit (CPU) 80. As is indicated in FIG. 3 by interconnection 82 betweenCPU 80 and battery 78, CPU 80 receives operating current from powersupply 78 with power being provided only when one or more of the signalsensors 74 are activated in the previously described manner. Aclock/calendar circuit 84 is connected to CPU 80 (via signal path 86 inFIG. 3 to allow time and date tagging of blood glucose tests and otherinformation. Although not specifically shown in FIG. 3 operating poweris supplied to clock/calendar 84 at all times.

[0046] In operation, CPU 80 receives and sends signals via a data bus(indicated by signal path 88 in FIG. 3 which interconnects CPU 80 withdual universal asynchronous receiver transmitters 70 and 72. The databus 88 also interconnects CPU 80 with memory circuits which, in thedepicted embodiment, include a system read-only memory (ROM) 90 aprogram random access memory (RAM) 92 and an electronically erasableread-only memory (EEROM) 94. System ROM 90 stores program instructionsand any data required in order to program data management unit 10 sothat data management unit 10 and a handheld microprocessor unit 12 thatis programmed with a suitable program cartridge 42 provide thepreviously discussed system operation and, in addition, system operationof the type described relative to FIGS. 4-10. During operation of thesystem, program RAM 92 provides memory space that allows CPU 80 to carryout various operations that are required for sequencing and controllingthe operation of the system of FIG. 1. In addition, RAM 92 can providememory space that allows external programs (e.g., programs provided byclearinghouse 54 to be stored and executed. EEROM 94 allows bloodglucose test results and other data information to be stored andpreserved until the information is no longer needed (i.e., untilpurposely erased by operating the system to provide an appropriate erasesignal to EEROM 94. FIGS. 4-10 illustrate typical screen displays thatare generated by the arrangement of the invention described relative toFIGS. 1-3 Reference will first be made to FIGS. 4 and 5 which exemplifyscreen displays that are associated with operation of the invention inthe blood glucose monitoring mode. Specifically, in the currentlypreferred embodiments of the invention, blood glucose monitor 16operates in conjunction with data management unit 10 and handheldmicroprocessor unit 12 to: (a) a test or calibration sequence in whichtests are performed to confirm that the system is operating properly;and, (b) the blood glucose test sequence in which blood glucose meter 16senses the user's blood glucose level. Suitable calibration proceduresfor blood glucose monitors are known in the art. For example, bloodglucose monitors often are supplied with a “code strip,” that isinserted in the monitor and results in a predetermined value beingdisplayed and stored in memory at the conclusion of the code stripcalibration procedure. When such a code strip calibration procedure isused in the practice of the invention, the procedure is selected fromone of the system menus. For example, if the system main menu includes a“monitor” menu item, a submenu displaying system calibration options andan option for initiating the blood glucose test may be displayed whenthe monitor menu item is selected. When a code strip option is availableand selected, a sequence of instructions is generated and displayed bydisplay screen 28 of handheld microprocessor unit 12 to prompt the userto insert the code strip and perform all other required operations. Atthe conclusion of the code strip calibration sequence, display unit 28of handheld microprocessor unit 12 displays a message indicating whetheror not the calibration procedure has been successfully completed. Forexample, FIG. 4 illustrates a screen display that informs the systemuser that the calibration procedure was not successful and that the codestrip should be inserted again (i.e., the calibration procedure is to berepeated). As is indicated in FIG. 4 display screens that indicate apotential malfunction of the system include a prominent message such asthe “Attention” notation included in the screen display of FIG. 4. Aspreviously indicated, the blood glucose test sequence that is employedin the currently preferred embodiment of the invention is of the type inwhich a test strip is inserted in a receptacle that is formed in theblood glucose monitor 16. A drop of the user's blood is then applied tothe test strip and a blood glucose sensing sequence is initiated. Whenthe blood glucose sensing sequence is complete, the user's blood glucoselevel is displayed.

[0047] In the practice of the invention, program instructions stored indata management unit 10 (e.g., system ROM 90 of FIG. 3) and programinstructions stored in program cartridge 42 of handheld microprocessorunit 12 cause the system to display step-by-step monitoring instructionsto the system user and, in addition, preferably result in display ofdiagnostic messages if the test sequence does not proceed in a normalfashion. Although currently available self-containedmicroprocessor-based blood glucose monitors also display testinstruction and diagnostic messages, the invention provides greatermessage capacity and allows multi-line instructions and diagnosticmessages that are displayed in easily understood language rather thancryptic error codes and abbreviated phraseology that is displayed oneline or less at a time. For example, as is shown in FIG. 5 the completeresults of a blood glucose test (date, time of day, and blood glucoselevel in milligrams per deciliter) can be concurrently displayed bydisplay screen 28 of handheld microprocessor unit 12 along with aninstruction to remove the test strip from blood glucose monitor 16. Aspreviously mentioned, when the blood glucose test is complete, the timeand date tagged blood glucose test result is stored in the memorycircuits of data management unit 10 (e.g., stored in EEPROM 94 of FIG.3) The arrangement shown and described relative to FIGS. 1-3 also isadvantageous in that data relating to food intake, concurrent medicationdosage and other conditions easily can be entered into the system andstored with the time and date tagged blood glucose test result for laterreview and analysis by the user and/or his or her healthcareprofessional. Specifically, a menu generated by the system at thebeginning or end of the blood glucose monitoring sequence can includeitems such as “hypoglycemic” and “hyperglycemic,” which can be selectedusing the switches of handheld microprocessor unit 12 (e.g., operationof control pad 30 and switch 36 in FIG. 1) to indicate the user wasexperiencing hypoglycemic or hyperglycemic symptoms at the time ofmonitoring blood glucose level. Food intake can be quantitativelyentered in terms of “Bread Exchange” units or other suitable terms by,for example, selecting a food intake menu item and using a submenudisplay and the switches of handheld microprocessor 12 to select andenter the appropriate information. A similar menu item—submenu selectionprocess also can be used to enter medication data such as the type ofinsulin used at the time of the glucose monitoring sequence and thedosage.

[0048] As was previously mentioned, program instructions stored in datamanagement unit 10 and program instructions stored in program cartridge42 of handheld microprocessor unit 12 enable the system to displaystatistical and trend information either in a graphic or alphanumericformat. As is the case relative to controlling other operational aspectsof the system, menu screens are provided that allow the system user toselect the information that is to be displayed. For example, in thepreviously discussed embodiments in which a system menu includes a“display” menu item, selection of the menu item results in the displayof one or more submenus that list available display options. Forexample, in the currently preferred embodiments, the user can selectgraphic display of blood glucose test results over a specific period oftime, such as one day, or a particular week. Such selection results indisplays of the type shown in FIGS. 6 and 7 respectively. When bloodglucose test results for a single day are displayed (FIG. 6) the day ofthe week and date can be displayed along with a graphic representationof changes in blood glucose level between the times at which testresults were obtained. In the display of FIG. 6 small icons identifypoints on the graphic representation that correspond to the bloodglucose test results (actual samples). Although not shown in FIG. 6coordinate values for blood glucose level and time of day can bedisplayed if desired. When the user chooses to display a weekly trendgraph (FIG. 7) the display generated by the system is similar to thedisplay of a daily graph, having the time period displayed inconjunction with a graph that consists of lines interconnecting pointsthat correspond to the blood glucose test results.

[0049] The screen display shown in FIG. 8 is representative ofstatistical data that can be determined by the system of FIG. 1 (usingconventional computation techniques) and displayed in alphanumericformat. As previously mentioned, such statistical data and informationin various other textual and graphic formats can be provided to ahealthcare professional (60 in FIG. 2) in the form of a standardizedreport 56 (FIG. 1) that is sent by clearinghouse 54 to facsimile machine55. In the exemplary screen display of FIG. 8 statistical data for bloodglucose levels over a period of time (e.g., one week) or, alternatively,for a specified number of monitoring tests is provided. In the exemplarydisplay of FIG. 8, the system (data management unit 10 or clearinghouse54 also calculates and displays (or prints) the average blood glucoselevel and the standard deviation. Displayed also is the number of bloodglucose test results that were analyzed to obtain the average and thestandard deviation; the number of test results under a predeterminedlevel (50 milligrams per deciliter in FIG. 8) and the number of bloodglucose tests that were conducted while the user was experiencinghypoglycemic symptoms. As previously noted, in the preferred embodimentsof the invention, a screen display that is generated during the bloodglucose monitoring sequence allows the user to identify the blood samplebeing tested as one taken while experiencing hyperglycemic orhypoglycemic symptoms and, in addition, allows the user to specify otherrelevant information such as food intake and medication information.

[0050] The currently preferred embodiments of the invention also allowthe user to select a display menu item that enables the user tosequentially address, in chronological order, the record of each bloodglucose test. As is indicated in FIG. 9, each record presented to thesystem user includes the date and time at which the test was conducted,the blood glucose level, and any other information that the userprovided. For example, the screen display of FIG. 9 indicates that theuser employed handheld microprocessor unit 12 as an interface to enterdata indicating use of 12.5 units of regular insulin; 13.2 units of“NPH” insulin; food intake of one bread exchange unit; and pre-mealhypoglycemic symptoms.

[0051] Use of data management unit 10 in conjunction with handheldmicroprocessor unit 12 also allows display (or subsequent generation ofa standardized report showing blood glucose test results along with foodintake and/or medication information. For example, shown in FIG. 10 is adaily graph in which blood glucose level is displayed in the mannerdescribed relative to FIG. 6. Related food intake and medication dosageis indicated directly below contemporaneous blood glucose levels byvertical bar graphs.

[0052] It will be recognized by those skilled in the art that theabove-described screen displays and system operation can readily beattained with conventional programming techniques of the type typicallyused in programming microprocessor arrangements. It also will berecognized by those skilled in the art that various other types ofscreen displays can be generated and, in addition, that numerous otherchanges can be made in the embodiments described herein withoutdeparting from the scope and the spirit of the invention.

[0053] It will also be recognized by those skilled in the art that theinvention can be embodied in forms other than the embodiments describedrelative to FIGS. 1-10. For example, the invention can employ compactvideo game systems that are configured differently than the previouslydiscussed handheld video game systems and palmcomputers. Morespecifically, as is shown in FIG. 11, a self-health monitoring systemarranged in accordance with the invention can employ a compact videogame system of the type that includes one or more controllers 100 thatare interconnected to a game console 102 via cable 104. As is indicatedin FIG. 11 game console 102 is connected to a video monitor ortelevision 106 by means of a cable 108. Although differing in physicalconfiguration, controller 100, game console 102, and the television orvideo monitor 106 collectively function in the same manner as thehandheld microprocessor 12 of FIG. 1. In that regard, a programcartridge 42 is inserted into a receptacle contained in game console 102with program cartridge 42 including stored program instructions forcontrolling microprocessor circuitry that is located inside game console102. Controller 100 includes a control pad 30 or other devicefunctionally equivalent to control pad 30 of FIG. 1 and switches thatfunctionally correspond to switches 32-38 of FIG. 1. Regardless ofwhether the invention is embodied with a handheld microprocessor unit 12(FIG. 1) or an arrangement such as the compact video game system (FIG.11) in some cases it is both possible and advantageous to apportion thesignal processing functions and operations differently than wasdescribed relative to FIGS. 1-10. For example, in some situations, themicroprocessor-based unit that is programmed by a card or cartridge(e.g., handheld unit 12 of FIG. 1 or compact video game console of FIG.11) includes memory and signal processing capability that allows themicroprocessor to perform all or most of the functions and operationsattributed to data management unit 10 of the embodiments discussedrelative to FIGS. 1-10. That is, the digitally encoded signal suppliedby blood glucose monitor 16 (or one of the other monitors 20 and 22 ofFIG. 1) can be directly coupled to the microprocessor included in gameconsole 102 of FIG. 11 or handheld microprocessor 12 of FIG. 1 In suchan arrangement, the data management unit 10 is a relatively simplesignal interface (e.g., interface unit of FIG. 11) the primary purposeof which is carrying signals between the blood glucose monitor 16 (orother monitor) and the microprocessor of game console 102 (FIG. 11) orhandheld unit 12 (FIG. 1) In some situations, the interface unit mayconsist primarily or entirely of a conventional cable arrangement suchas a cable for interconnection between RS-232 data ports or otherconventional connection arrangements. On the other hand, as is shown inFIG. 11 signal interface 110 can either internally include or beconnected to a modem 52, which receives and transmits signals via atelephone line 50 in the manner described relative to FIGS. 1 and 2.

[0054] It also should be noted that all or a portion of the functionsand operations attributed to data management unit 10 of FIG. 1 can beperformed by microprocessor circuitry located in blood glucoase monitor16 (or other monitor that is used with the system). For example, anumber of commercially available blood glucose monitors include aclock/calendar circuit of the type described relative to FIG. 3 and, inaddition, include microprocessor circuitry for generating visual displaysignals and signals representative of both current and past values ofmonitored blood glucose level. Conventional programming and designtechniques can be employed to adapt such commercially available unitsfor the performance of the various functions and operations attributedin the above discussion of FIGS. 1-11 to data management unit 10 and/orthe microprocessors of handheld unit 12 and compact video console 102.In arrangements in which the blood glucose monitor 16 (or other systemmonitor) includes a microprocessor that is programmed to provide signalprocessing in the above-described manner, the invention can use a signalinterface unit 110 of the above-described type. That is, depending uponthe amount of signal processing effected by the monitoring unit (e.g.,blood glucoase monitor 16) and the amount of signal processing performedby the microprocessor of video game console 102 (or handheld unit 12)the signal interface required ranges from a conventional cable (e.g.,interconnection of RS-232 ports) to an arrangement in which signalinterface 110 is arranged for signal communication with an internal orexternal modem (e.g., modem 52 of FIG. 11) or an arrangement in whichsignal interface 110 provides only a portion of the signal processingdescribed relative to FIGS. 1-10. The invention also is capable oftransmitting information to a remote location (e.g., clearinghouse 54and/or a remotely located healthcare professional) by means other thanconventional telephone lines. For example, a modem (52 in FIGS. 1 and11) that is configured for use with a cellular telephone system can beemployed to transmit the signals provided by the healthcare monitoringsystem to a remote location via modulated RF transmission. Moreover, theinvention can be employed with various digital networks such as recentlydeveloped interactive voice, video and data systems such as televisionsystems in which a television and user interface apparatus isinteractively coupled to a remote location via coaxial or fiberopticcable and other transmission media (indicated in FIG. 11) by cable 112which is connected to television or video monitor In such anarrangement, compact video game controller and the microprocessor ofvideo game console 102 can be programmed to provide the user interfacefunctions required for transmission and reception of signals via theinteractive system. Alternatively, the signals provided by video gameconsole 102 (or handheld unit if FIG. 1) can be supplied to the userinterface of the interactive system (not shown in FIG. 11) in a formatthat is compatible with the interactive system and allows the systemuser interface to be used to control signal transmission between thehealthcare system and a remote facility such as clearinghouse 54 FIGS. 1and 2.

1. A networked health-monitoring system comprising: a plurality ofremote patient sites, each site including at least one display; a datamanagement unit 10 configured to facilitate collection of patienthealth-related data; a memory and stored program instructions forgenerating health-monitoring related information on the display; and atleast one central server connectable for communication with the datamanagement units at the patient sites to receive patient health-relateddata collected at the remote patient sites, wherein the system isconfigured to produce reports, including standardized reports, from thereceived data.
 2. The system of claim 1, wherein the system isconfigured to allow a health care professional to select which of aplurality of standardized reports is produced.
 3. The system of claim 2,wherein the reports use graphs and/or icons.
 4. The system of claim 2,wherein the reports can be generated periodically.
 5. The system ofclaim 3 wherein the server can generate the report.
 6. The system ofclaim 1, wherein the system is configured to cause the presentation ofat least one report on the display at a remote patient site.
 7. Thesystem of claim 1, wherein the reports includes formatted statistical ortrend information.
 8. The system of claim 2, wherein the report includesinformation data for a period of time.
 9. The system of claim 7, whereinthe system can display statistical or trend information to the patient.10. The system of claim 2, wherein the report includes information datafor a period of time.
 11. The system of claim 2, further comprising atleast one health care professional computer, remotely located from andin signal communication with the central server.
 12. The system of claim2, further comprising at least one health-monitoring device configuredto monitor at least one patient health condition at at least one remotepatient site and to communicate data related to the monitored conditionto the central server.
 13. The system of claim 11, wherein the datamanagement unit facilitates collection of health-related data byreceiving data related to the monitored condition from at least one ofthe health-monitoring devices.
 14. The system of claim 11, wherein atleast one of the health-monitoring devices includes one or more of theset consisting of a blood glucose monitor; a peak flow meter; a bloodpressure monitor; a pulse monitor; and a body temperature monitor. 15.The system of claim 2, wherein the data management unit is configured tofacilitate collection of health-related data entered by a patient at theremote patient site using buttons, keys or switches.
 16. The system ofclaim 11, wherein the data management unit is physically separate fromthe display.
 17. The system of claim 15, wherein the memory and thedisplay form a part of one of the health-monitoring devices.
 18. Thesystem of claim 16, wherein the display is in a handheld device.
 19. Thesystem of claim 17, wherein the handheld device is capable of displayingpictorial health-monitoring related information
 20. The system of claim18, wherein the handheld device is capable of displaying animatedhealth-monitoring related information.
 21. The system of claim 19,wherein the memory is a program cartridge
 22. The system of claim 1,wherein the remote sites further include at least one personal computerconnected to the data management unit.
 23. The system of claim 1,wherein the system is configured to transmit a message for display on atleast one display.
 24. The system of claim 22, wherein the messageincludes step-by-step instructions.
 25. The system of claim 22, whereinthe message are results of a test.
 26. The system of claim 22, whereinthe message includes a diagnostic indication related to whether a testhas proceeded in a normal fashion.
 27. The system of claim 22, whereinthe message is a multi-line message.
 28. The system of claim 22, whereinthe messages is a health care professional selected message.
 29. Thesystem of claim 27 wherein the health-care professional generates theselected message.
 30. The system of claim 22, wherein the message iseducational or motivational.
 31. The system of claim 27, wherein thesystem is configured to cause message to be transmitted to a specificpatient.
 32. The system of claim 27, wherein the system is configured tocause the message to be transmitted automatically to the patient. 33.The system of claim 27, wherein system enables the patient to choosewhen to receive the message.
 34. The system of claim 27, wherein themessages can be stored before being transmitted to the patient.
 35. Thesystem of claim 2, wherein the system is configured to allow the patientto control the display of information using at least one menu.
 36. Thesystem of claim 35, wherein the menu allows the patient to select anyone of the operational modes from the set consisting of: a display modefor displaying relevant information; an input mode for providinginformation; and a communications mode for establishing a link with thecentral server.
 37. The system of claim 35, wherein the menu allows apatient to select a monitoring mode in which at least one of thehealth-monitoring devices is used.
 38. The system of claim 35, whereinthe menu allows a patient to display messages or instructions from ahealth care professional.
 39. The system of claim 2, wherein the systemis configured to enable the patient to respond to information on thedisplay by using a cursor or other indicator positioned at a selecteditem.
 40. The system of claim 2, wherein the system is configured toenable programs to be provided, from the server for storage in a memoryand execution at a remote patient site.
 41. The system of claim 1,wherein the patient can indicate user experienced symptoms to thesystem.
 42. The system of claim 1, wherein the system can capturequantitative measurements.
 43. The system of claim 42, wherein thesystem can capture medication data.
 44. The system of claim 1, whereinthe collected patient health-related data includes time data.
 45. Thesystem of claim 1, wherein the healthcare professional computer receivesthe report after transmitting an authorization code to the server thatidentifies an associated healthcare professional as an authorized user.46. A method of collecting and processing patient health-related data,comprising: at a plurality of remote patient sites using stored programinstructions to generate health-monitoring related information on atleast one display; facilitating collection of patient health-relateddata using a data management unit; and collecting patient health-relateddata; connecting at least one central server for communication with thedata management units at the patient sites to receive patienthealth-related data collected at the remote patient sites; and producingreports, including standardized reports, from the received data.
 47. Themethod of claim 46, further comprising allowing a health careprofessional to select which of a plurality of standardized reports isproduced.
 48. The method of claim 47, wherein the reports use graphsand/or icons.
 49. The method of claim 47, wherein the reports can begenerated periodically.
 50. The system of claim 46 wherein the servergenerates the report.
 51. The method of claim 46, further comprisingpresenting at least one report on a display at a remote patient site.52. The method of claim 46, wherein the report includes statistical ortrend information.
 53. The method of claim 52, wherein furthercomprising displaying statistical or trend information to the patient54. The method of claim 46, wherein the report includes information datafor a period of time.
 55. The method of claim 47, further comprisingremotely locating and placing in signal communication at least onehealth care professional computer with the central server.
 56. Themethod of claim 47, further comprising using at least one healthmonitoring device to monitor at least one patient health condition atleast one remote patient site; and to communicate data related to themonitored condition to the central server.
 57. The method of claim 56,wherein the data management unit facilitates collection ofhealth-related data by receiving data related to the monitored conditionfrom at least one of the health-monitoring devices.
 58. The method ofclaim 56, wherein at least one health monitoring device includes one ormore of the set consisting of a blood glucose monitor; a peak flowmeter; a blood pressure monitor; a pulse monitor; and a body temperaturemonitor.
 59. The method of claim 47, wherein the data managementfacilitates collection of health-related data entered by a patient atthe remote patient site using buttons, keys or switches.
 60. The methodof claim 56, wherein the data management unit is physically separatefrom the display.
 61. The method of claim 59, wherein the memory and thedisplay form part of at least one of the health-monitoring devices. 62.The method of claim 60, wherein the display is in a handheld device. 63.The method of claim 62, wherein the memory is a program cartridge. 64.The method of claim 61, wherein the handheld device is capable ofdisplaying pictorial health-monitoring related information
 65. Themethod of claim 62, wherein the handheld device is capable of displayinganimated health-monitoring related information.
 66. The method of claim46, wherein the remote sites further include at least one personalcomputer connected to the data management unit.
 67. The method of claim46, further comprising transmitting at least one message and displayingit on at least one remote patient site display.
 68. The method of claim65, wherein the message includes step-by-step instructions.
 69. Themethod of claim 65, wherein the message includes results of a test. 70.The method of claim 65, wherein the message includes diagnosticinformation indicating whether a test has proceeded in a normal fashion.71. The method of claim 65, wherein the message is a multi-line message.72. The method of claim 65, wherein the message is a health careprofessional selected message.
 73. The method of claim 69, wherein thehealth-care professional generates the selected message.
 74. The methodof claim 65, wherein the message is educational or motivational.
 75. Themethod of claim 69, wherein the message is transmitted to a specificpatient.
 76. The method of claim 69, wherein the message is transmittedautomatically to the patient.
 77. The method of claim 69, wherein thepatient chooses when to receive the message.
 78. The method of claim 69,wherein the message is stored before being transmitted to the patient.79. The method of claim 47, wherein the patient controls the display ofinformation using at least one menu.
 80. The method of claim 76, whereinthe menu allows a patient to select any one of the operational modesfrom the set consisting of: a display mode for displaying relevantinformation; an input mode for providing information; and acommunications mode for establishing a link with the central server. 81.The method of claim 76, wherein the menu allows a patient to select amonitoring mode in which at least one of the health-monitoring devicesis used.
 82. The method of claim 76, wherein the menu allows a patientto display messages or instructions from a health care professional. 83.The method of claim 47, wherein the patient responds to information onthe display by using a cursor or other indicator positioned at aselected item.
 84. The method of claim 47, further comprising: providinga program from the server to a remote patient site; and storing in amemory and executing the program at the remote patient site.
 85. Themethod of claim 46, wherein the collected patient health-related dataincludes user-experienced symptoms.
 86. The method of claim 46, whereincollected patient health-related data includes the system can capturequantitative measurements.
 87. The method of claim 46, wherein thesystem can capture medication data.
 88. The system of claim 1, whereinthe collected patient health-related data includes time data.
 89. Themethod of claim 46, receiving the report after transmitting anauthorization code to the server that identifies an associatedhealthcare professional as an authorized user.
 90. A networkedhealth-monitoring system comprising: a plurality of remote patientsites, each site including means for display information; a datamanagement unit means for facilitating collection of patienthealth-related data; a memory means and stored program means forgenerating health-monitoring related information on the display; atleast one central server for communication with the data management unitmeans at the patient sites to receive patient health-related datacollected at the remote patient sites; and means for producing reports,including standardized reports, from the received data.